Brain imaging in young patients with acute leukemia
A Pilot Study of Brain Magnetic Resonance Fingerprinting in Children, Adolescents and Young Adults With Acute Leukemia
This study is testing how chemotherapy affects the brains of children and young adults with acute leukemia to see if it causes any thinking problems and to find ways to help them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, Methotrexate |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06421155 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the neurocognitive effects of chemotherapy in children, adolescents, and young adults diagnosed with acute leukemia by utilizing a brain imaging technique called Magnetic Resonance Fingerprinting (MRF). Participants will undergo MRF scans at diagnosis and at various points during and after their chemotherapy treatment to assess changes in brain matter. The goal is to identify those at risk for cognitive impairments resulting from chemotherapy and to develop strategies to mitigate these effects, thereby improving long-term quality of life for survivors.
Who should consider this trial
Good fit: Ideal candidates for this study are children, adolescents, and young adults aged 0 to 30 years who have been diagnosed with acute leukemia.
Not a fit: Patients who do not have acute leukemia or are outside the age range of 0 to 30 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of neurocognitive side effects in young leukemia patients, enhancing their quality of life post-treatment.
How similar studies have performed: Other studies have indicated the potential for neurocognitive deficits in leukemia survivors, suggesting that this approach to monitoring and mitigating those effects is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age range: 0 - 30 years * Participants from University Hospitals Rainbow Babies \& Children's Hospital, UH Seidman Cancer Center, and participants referred from outside facilities diagnosed with acute leukemia. * Meets diagnostic criteria for acute leukemia including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) and myeloproliferative neoplasm/leukemia. * Participants must have the ability to understand and the willingness to sign a written informed consent document. Participants who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document. Participants who are between the ages of 7 to 13 will be given an information sheet that explains the study to them. The information sheet may be used for study participants between the ages of 14-17 if it would better inform the child about the nature and procedures that will undergo as a participant in the study. Exclusion Criteria: * Individuals that are \>2 weeks into the induction chemotherapy for acute leukemia. * Individuals with either a heart pacemaker, heart defibrillator, metal in the eye, some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, some other implanted devices, or any other MRI contraindication
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Mari Dallas, MD — University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital, Case Comprehensive Cancer Center
- Study coordinator: Mari Dallas, MD
- Email: Mari.dallas@uhhospitals.org
- Phone: 216-844-6223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.